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- Title
Schedule-selective biochemical modulation of 5-fluorouracil in advanced colorectal cancer -- a phase II study.
- Authors
Tomlinson, Shannon K.; Melin, Susan A.; Higgs, Vetta; White, Douglas R.; Savage, Paul; Case, Douglas; Blackstock, William A.
- Abstract
Background: 5-fluorouracil remains the standard therapy for patients with advanced/metastatic colorectal cancer. Pre-clinical studies have demonstrated the biological modulation of 5- fluorouracil by methotrexate and leucovorin. This phase II study was initiated to determine the activity and toxicity of sequential methotrexate -- leucovorin and 5-fluorouracil chemotherapy in patients with advanced colorectal cancer. Methods: Ninety-seven patients with metastatic colorectal cancer were enrolled onto the study. Methotrexate -- 30 mg/m² was administered every 6 hours for 6 doses followed by a 2 hour infusion of LV -- 500 mg/m². Midway through the leucovorin infusion, patients received 5-fluorouracil -- 600 mg/m². This constituted a cycle of therapy and was repeated every 2 weeks until progression. Results: The median age was 64 yrs (34-84) and the Eastern Cooperative Group Oncology performance score was 0 in 37%, 1 in 55% and 2 in 8% of patients. Partial and complete responses were seen in 31% of patients with a median duration of response of 6.4 months. The overall median survival was 13.0 months. The estimated 1-year survival was 53.7%. Grade III and IV toxic effects were modest and included mucositis, nausea and vomiting. Conclusions: This phase II study supports previously reported data demonstrating the modest clinical benefit of 5-FU modulation utilizing methotrexate and leucovorin in patients with metastatic colorectal cancer. Ongoing studies evaluating 5-fluorouracil modulation with more novel agents (Irinotecan and/or oxaliplatin) are in progress and may prove encouraging.
- Subjects
FLUOROURACIL; COLON cancer; METHOTREXATE; FOLINIC acid; CANCER patients
- Publication
BMC Cancer, 2002, Vol 2, p9
- ISSN
1471-2407
- Publication type
Article
- DOI
10.1186/1471-2407-2-9